Aortic Valve Surgery Clinical Trial
— PRAGUEOfficial title:
Use of the SonoSite Probe for Measuring Jugular Venous Pressure
NCT number | NCT03815188 |
Other study ID # | STH20529 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 15, 2019 |
Est. completion date | August 31, 2019 |
Verified date | August 2019 |
Source | Sheffield Teaching Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This prospective study will be performed in the Cardiothoracic (Chesterman) Department at
Sheffield Teaching Hospitals NHSFT, Northern General Hospital. Pre-operative patients
undergoing surgical valvular intervention, breathing both spontaneously and mechanically will
be included in the trial. All patients will already have a central venous catheter inserted
as part of their ongoing care. Patients will be eligible for the study irrespective of
diagnosis or neck size. Patient demographical data will be recorded by Sam Jenkins following
written consent, the day before the trial.
The goal of this study is to determine if ultrasound assessment of Jugular Venous Pressure
(JVP) accurately predicts Central Venous Pressure (CVP). Secondary objectives aim to identify
if using the angle of Louis to approximate the location of the right atrium produces
inaccuracies when measuring JVP. Comparing results in patients breathing spontaneously or
under positive pressure ventilation will identify if the form of ventilation impacts on JVP
and CVP recording. Correlating results between physical JVP examination and ultrasound
assessment of JVP to measure CVP will conclude if ultrasound is a more appropriate tool, in
an era where the physical examination of the cardiovascular system is becoming less valuable.
Status | Completed |
Enrollment | 124 |
Est. completion date | August 31, 2019 |
Est. primary completion date | June 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients undergoing cardiac surgery - Patients who have a central line inserted during surgery - Patients able and willing to give consent in verbal and written English. Exclusion Criteria: - Patients under the age of 18 - Patients unable to provide consent in verbal and written English - Patients with thyroid enlargement or alternative reason causing obstruction to venous anatomy - Patients with significant tricuspid regurgitation |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Sheffield Teaching Hospitals NHS FT | Sheffield | England |
Lead Sponsor | Collaborator |
---|---|
Sheffield Teaching Hospitals NHS Foundation Trust | University of Sheffield |
United Kingdom,
Brennan JM, Blair JE, Goonewardena S, Ronan A, Shah D, Vasaiwala S, Brooks E, Levy A, Kirkpatrick JN, Spencer KT. A comparison by medicine residents of physical examination versus hand-carried ultrasound for estimation of right atrial pressure. Am J Cardiol. 2007 Jun 1;99(11):1614-6. Epub 2007 Apr 18. — View Citation
Cook DJ, Simel DL. The Rational Clinical Examination. Does this patient have abnormal central venous pressure? JAMA. 1996 Feb 28;275(8):630-4. — View Citation
Deol GR, Collett N, Ashby A, Schmidt GA. Ultrasound accurately reflects the jugular venous examination but underestimates central venous pressure. Chest. 2011 Jan;139(1):95-100. doi: 10.1378/chest.10-1301. Epub 2010 Aug 26. — View Citation
Fletcher RH, Fletcher SW. Has medicine outgrown physical diagnosis? Ann Intern Med. 1992 Nov 1;117(9):786-7. — View Citation
Jang T, Aubin C, Naunheim R, Char D. Ultrasonography of the internal jugular vein in patients with dyspnea without jugular venous distention on physical examination. Ann Emerg Med. 2004 Aug;44(2):160-8. — View Citation
Lipton B. Estimation of central venous pressure by ultrasound of the internal jugular vein. Am J Emerg Med. 2000 Jul;18(4):432-4. — View Citation
Mangione S, Nieman LZ. Cardiac auscultatory skills of internal medicine and family practice trainees. A comparison of diagnostic proficiency. JAMA. 1997 Sep 3;278(9):717-22. Erratum in: JAMA 1998 May 13;279(18):1444. — View Citation
Seth R, Magner P, Matzinger F, van Walraven C. How far is the sternal angle from the mid-right atrium? J Gen Intern Med. 2002 Nov;17(11):852-6. — View Citation
Socransky SJ, Wiss R, Robins R, Anawati A, Roy MA, Yeung IC. Defining normal jugular venous pressure with ultrasonography. CJEM. 2010 Jul;12(4):320-4. — View Citation
Sondergaard S, Parkin G, Aneman A. Central venous pressure: we need to bring clinical use into physiological context. Acta Anaesthesiol Scand. 2015 May;59(5):552-60. doi: 10.1111/aas.12490. Epub 2015 Feb 13. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ultrasonography | Ultrasonography is expected to be a more accurate measure of CVP compared to physical JVP examination and is hypothesised to accurately predict CVP. | Through study completion - 30/09/2019 |
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